Cause of Device-Related Incident
Device factors

Clinical Specialty or Hospital Department
CSR / Materials Management; OR / Surgery

Device Factors
Manufacturing error

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Infection; Particulates

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
*Not stated

UMDNS
Bandages, Elastic [10-279]; Bandages, Pressure [10-284]

Excessive Cornstarch Powder on Latex (Esmark) Bandages



Hazard [Health Devices Apr 1996;25(4):150]

Problem

A member hospital reported finding clumps of excessive cornstarch on latex (Esmark) bandages. The reporting hospital is concerned that these clumps, exposed as the bandage is unrolled, may drop onto the operative area.

Discussion

This disposable product is typically used as a compression bandage to tightly wrap extremities before surgery, thereby providing a bloodless surgical field. Like many other latex medical products, the bandages are dusted with cornstarch powder to prevent the material from adhering to itself while in storage or during use.

Cornstarch, a U.S.P. material, has been used for many years on latex medical products to make the material easier to work with. It replaced talc powder when research demonstrated that talc cannot be absorbed by the body and could be a source of postoperative granulomas. Although cornstarch is sterile and can be absorbed by the body, some studies have shown that it too has been associated with granulomas in surgical wounds.(1)

More recently, with the growing awareness of individuals' allergic sensitivities to latex in the healthcare workplace, cornstarch has also been recognized as a vector for transporting latex antigens and inducing allergic reactions when the powder is aerosolized from latex products.(2) The resulting reactions (e.g., anaphylaxis) can be life threatening.

While postoperative complications attributable to cornstarch exposure occur infrequently, and problems of hypersensitivity may be even rarer, both are preventable. Therefore, efforts should be made to avoid unnecessary exposure to cornstarch on latex products.

The manufacturer states that controlling the process of cornstarch application is difficult and that it tries to minimize powder application while still using enough to prevent the latex from sticking to itself. It also says that, although powder-free latex bandages can be manufactured, existing methods may make such products prohibitively expensive for some customers. The company reports that it is unaware of any industry standards for acceptable levels of cornstarch on latex medical products.

Recommendations

  1. Alert staff to the possibility of excessive cornstarch on latex products, particularly bandages. Have them review current practices concerning the use of these bandages, specifically their use near sterile fields or uncovered operative areas.
  2. If excessive powder on the bandages is likely to contaminate the operative field, suggest that staff unroll and inspect the bandages for excessive powder (using sterile technique and keeping the bandages away from the patient) before wrapping limbs. If clumps are noted, the bandage should not be applied. (We are unaware of any practical way to effectively remove excessive powder without compromising the use of the bandages.)
  3. Consider the use of alternative products, such as powder-free latex bandages or nonlatex bandages.

Notes

  1. Sternlieb JJ, McIlrath DC, van Heerden, et al. Starch peritonitis and its prevention. Arch Surg 1977 Apr;112(4):458-61.
  2. Breezhold D, Beck W. Surgical  glove powders bind latex antigens Arch Surg 1992 Nov;1127(11):1354-7.

UMDNS Terms

  • Bandages, Elastic [10-279]
  • Bandages, Pressure [10-284]

Cause of Device-Related Incident

Device factor: Manufacturing error

Mechanism of Injury or Death

Infection; Particulates


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